Geron Corporation · 8 hours ago
Vice President, Regulatory Affairs
United States
Full-time
Remote
Director/Executive
$320K/yr - $350K/yr
15+ years expGeron Corporation is seeking a Vice President of Regulatory Affairs to lead and implement their regulatory strategy. The VP will be responsible for regulatory recommendations, managing relationships with health authorities, and overseeing all regulatory activities throughout product development and commercialization.
BiopharmaBiotechnologyHealth DiagnosticsOncologyPharmaceutical
Responsibilities
Build and retain highly effective team of regulatory professionals, and through leadership and direct line management, facilitates personal development and training of team members to ensure successful execution of global regulatory activities and strategies for the Company’s product development programs
Leadership of cross-function teams where appropriate to achieve corporate goals, especially where regulatory activities form a significant contribution
Develop and implement RA strategies and plans during clinical development and in preparation for the anticipated registration filings, including ODD and PIP strategies
Identify and assess regulatory risks, including regional and global market-related drivers
Lead and oversee regulatory submissions for hematology/oncology products, including health authority communication strategies
Implement and integrate best regulatory practices into pre-clinical, clinical, and CMC submissions and ensure that all regulatory submissions are appropriately reviewed, complete, scientifically accurate, and of high quality
Lead responses to and/or resolution of regulatory inquiries from agencies and health authorities and represents RA at meetings and interactions with regulatory agencies
Contribute to the creation of development plans that incorporate regulatory strategies designed to maximize the likelihood of successful regulatory applications, delivering regulatory approval, advantageous labeling, and reimbursement for all key indications
Serve as a credible, influential, respected Company spokesperson during interactions with US and ex-US regulatory agencies and drive appropriate, proactive communications to assure expedient and efficient review and approval of submissions
Monitor and anticipate regulatory and scientific advances, novel endpoints, innovative clinical trial designs, and regularly brief Company management
Lead the preparation and management of timely regulatory submissions, including INDs, briefing documents, clinical protocols, NDAs/MAAs, fast-track, breakthrough designation, accelerated approval, and orphan drug applications
Fulfill all requirements for ensuring reporting obligations are met, including amendments, annual reports to FDA, safety, and quality reports
Lead and contribute to process improvement initiatives, and development of department SOPs
Collaborate with clinical and drug safety to manage the regulatory aspects of the Company systems, and providing the regulatory oversight and reporting requirements
Review and approval of clinical study protocols, CSRs, SAPs, DSUR, IBs, and ISS
Collaborate on the preparation of regulatory submissions, including post-marketing commitments, safety updates, and payer evidence packages as part of RDLT Collaborate with Manufacturing and Quality to manage regulatory aspects of all CMC activities, including regulatory evaluation of CMC change controls
Assess and align the organization to meet the goals of the long-range business plan
Represent the Regulatory department in internal leadership forums, external presentations, and cross-functional governance bodies
Qualification
Required
Significant regulatory expertise in hematology/oncology drug development with deep understanding of US & EU and other regulatory requirements and environment
Detailed knowledge and in-depth application of GCP, GMP, FDA, and EU GVP regulations and international guidelines
Ability to read, evaluate, and interpret complex regulatory documents and to respond effectively to sensitive inquiries or issues
Ability to lead and collaborate across cross-functional teams, including CROs and external vendors
Ability to successfully manage activities to timelines, lead and develop people, and work in a multi-disciplinary team environment
People management strengths, including the ability to motivate and mentor
Willingness to roll-up sleeves and be hands-on
Excellent written and verbal communication skills
Excellent scientific analysis and interpretation skills and the ability to creatively problem solve
Strategic mindset with the ability to drive plans for successful regulatory outcomes
Minimum of 15 years of experience in pharmaceutical or biopharmaceutical industry, the majority in a hematology/oncology setting
Extensive Regulatory Affairs management experience in early and late-stage clinical settings, including oversight of third-party regulatory activities, internal pharmacovigilance review processes and clinical safety assessments, reporting procedures, and risk management
IND/NDA/MAA preparation and product registration experience, with demonstrated track record of success with drug approvals
Drug development experience in orphan diseases
Preferred
Advanced degree (MS or PhD) or equivalent preferred
Benefits
Medical
Dental
Vision
Life insurance
Flexible spending accounts
Disability insurance
Supplemental health insurance
401(k) retirement savings plan
Employee stock purchase plan
Generous time off program
160 hours of vacation during each full year of employment
64 hours of sick leave
9 standard paid holiday days off
Paid leave for certain life events
Company
Geron Corporation
Geron is a biopharmaceutical company that is charting a new course with the goal to deliver innovative treatment options for people living with blood cancer.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
$999.54MKey Investors
Pharmakon Advisors
2024-11-07Post Ipo Debt· $250M
2024-03-19Post Ipo Equity· $150M
2023-01-05Post Ipo Equity· $227.84M
Leadership Team
Harout Semerjian
President & CEO
Michelle Robertson
Chief Financial Officer
Recent News
New Enterprise Associates
2026-01-02
2025-12-19
2025-12-18
Company data provided by crunchbase